{"answer":{"query":"Tabrecta","resolved_as":"applications","packages":4,"applications":["NDA213591"],"identity":{"application_numbers":["NDA213591"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2020-05-06","latest":"2020-05-06","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA213591","date":"2035-07-22","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled)","driver":{"kind":"patent","ref":"10596178","productNo":"001"},"latest_patent_expiry":"2035-07-22","latest_exclusivity_expiry":"2027-05-06","dated_barriers":16,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":1,"fact_id":"8e8f9bde28fd6c665c6b5195"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"LABELING":3,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA213591","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-03-14","documents":[{"type":"Letter","date":"2024-03-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213591Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-03-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213591s011lbl.pdf","untrusted":true}}],"fact_id":"dff7b64c73fc8cd546433acc"},{"application":"NDA213591","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-03-24","documents":[{"type":"Letter","date":"2023-03-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213591Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-03-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213591s007lbl.pdf","untrusted":true}}],"fact_id":"f3505e71880bae52da4392d4"},{"application":"NDA213591","submission_no":4,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-08-10","documents":[{"type":"Letter","date":"2022-08-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213591Orig1s004ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-08-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s004lbl.pdf","untrusted":true}}],"fact_id":"7306765463db01d4e2d26099"},{"application":"NDA213591","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-01-21","documents":[{"type":"Letter","date":"2022-01-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213591Orig1s002ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-01-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s002lbl.pdf","untrusted":true}}],"fact_id":"0c157aa87e01e7fbba1e1af6"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":2},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"NDA213591","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TABRECTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 200MG BASE","untrusted":true}},{"application":"NDA213591","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TABRECTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 150MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Capmatinib Hydrochloride","untrusted":true},"brand":{"text":"Tabrecta","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":17063604.91,"claims":976,"beneficiaries":319,"average_spending_per_claim_usd":17483.201752,"fact_id":"f9be79ff8c6030f17b1fc0ea"},{"year":2021,"gross_spending_usd":50107244.39,"claims":2860,"beneficiaries":651,"average_spending_per_claim_usd":17520.015521,"fact_id":"03a5de659188bc0ff0a5a10a"},{"year":2022,"gross_spending_usd":70283871.62,"claims":3922,"beneficiaries":780,"average_spending_per_claim_usd":17920.416017,"fact_id":"ffb521b234e657bc74505f2b"},{"year":2023,"gross_spending_usd":93104406.99,"claims":4864,"beneficiaries":978,"average_spending_per_claim_usd":19141.531042,"fact_id":"f79f3757f3926d807b9b69bc"},{"year":2024,"gross_spending_usd":124105409.21,"claims":6477,"beneficiaries":1169,"average_spending_per_claim_usd":19160.940128,"fact_id":"11cb2caef60552f54aba845e"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"orphan_designation":{"ingredients":[{"ingredient":{"text":"capmatinib","untrusted":true},"designation_count":1,"approved_count":1,"recent":[{"designated":"2019-03-15","use":{"text":"Treatment of non-small cell lung cancer with MET genomic tumor aberrations","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Novartis Pharmaceuticals Corp.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"7b7816648e2e5328f0b194df"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2024,"states_with_data":0,"all_states_medicaid_reimbursed_usd":0,"all_states_medicaid_paid_prescriptions":0,"top_states":[],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":246,"medicaid_reimbursed_usd":4817154.9,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":0,"dataset":"State Drug Utilization Data 2024","read_on":"2026-11-07T23:59:45.983Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). Reimbursement is before manufacturer rebates: not a net cost, not a patient price. Suppressed managed-care cells make a state figure fee-for-service only. An absent state was suppressed or unreported, not zero.","receipts_note":"a receipt is held for the largest fact behind each state shown; every figure is a sum of the built_from_facts facts, each recomputable from its recorded input hash"}},"receipts":[{"fact_id":"a286a39b39b12bad04c0677b","field":"ndc.listing","entity":"ndc:00078070956"},{"fact_id":"b267653d87dd8f5f48e8dac0","field":"ndc.listing","entity":"ndc:00078070994"},{"fact_id":"58150664cee521a12d811095","field":"ndc.listing","entity":"ndc:00078071656"},{"fact_id":"8e8f9bde28fd6c665c6b5195","field":"drug.generic_entry_earliest","entity":"application:NDA213591"},{"fact_id":"edffbf850cb9a4ba079f3047","field":"drug.patent","entity":"application:NDA213591"},{"fact_id":"a58e415e2cd566c94908ee09","field":"drug.exclusivity","entity":"application:NDA213591"},{"fact_id":"dff7b64c73fc8cd546433acc","field":"drug.label_event","entity":"application:NDA213591"},{"fact_id":"f3505e71880bae52da4392d4","field":"drug.label_event","entity":"application:NDA213591"},{"fact_id":"7306765463db01d4e2d26099","field":"drug.label_event","entity":"application:NDA213591"},{"fact_id":"0c157aa87e01e7fbba1e1af6","field":"drug.label_event","entity":"application:NDA213591"},{"fact_id":"f394416b07082107acde8a6d","field":"drug.marketing_status","entity":"application:NDA213591"},{"fact_id":"c9eab9a419c95b23790a4f7f","field":"drug.marketing_status","entity":"application:NDA213591"},{"fact_id":"f9be79ff8c6030f17b1fc0ea","field":"drug.partd_spending","entity":"drug:capmatinib-hydrochloride|tabrecta"},{"fact_id":"03a5de659188bc0ff0a5a10a","field":"drug.partd_spending","entity":"drug:capmatinib-hydrochloride|tabrecta"},{"fact_id":"ffb521b234e657bc74505f2b","field":"drug.partd_spending","entity":"drug:capmatinib-hydrochloride|tabrecta"},{"fact_id":"f79f3757f3926d807b9b69bc","field":"drug.partd_spending","entity":"drug:capmatinib-hydrochloride|tabrecta"},{"fact_id":"11cb2caef60552f54aba845e","field":"drug.partd_spending","entity":"drug:capmatinib-hydrochloride|tabrecta"},{"fact_id":"7b7816648e2e5328f0b194df","field":"drug.orphan_designation","entity":"drug:capmatinib"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["GREEN"],"note":"Source records are public; this compilation is cited with attribution. See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"NO_DATA","field":"biologic_status","reason":"no biologic application of this drug has a Purple Book status in the edition (a drug that is not a biologic has none)"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}